CHMP recommends updated Omicron vaccine

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended authorising an adapted COVID-19 Comirnaty vaccine targeting the Omicron XBB.1.5 subvariant.

Omicron XBB.1.5 COVID-19 vaccine indications

Individuals from five years of age who require vaccination should have a single dose, irrespective of their COVID-19 vaccination history.

One dose is recommended for individuals six months of age and older. Additionally, the updated COVID-19 vaccine is recommended for children from six months to four years old. These individuals can have one or three doses. This is dependent on whether they have completed a primary vaccination course or have had COVID-19.

The EMA’s human medicines committee evaluated all the available data on Pfizer Inc. and BioNTech SE’s Comirnaty and their other adapted vaccines.

Furthermore, the Committee assessed new laboratory data showing a strong response of the adapted vaccine against XBB.1.5 and related strains that cause the COVID-19 virus.

Recommendation by the CHMP is based on pre-clinical data. It showed that the adapted monovalent COVID-19 vaccine generates an improved response against multiple XBB-related sublineages. This includes the globally dominant XBB.1.5, XBB.1.16, XBB.2.3, and EG.5.1 (Eris) sublineages.

“This season’s vaccine is ready to ship as soon as the final regulatory decision is made,” stated Albert Bourla, Chairman and Chief Executive Officer at Pfizer. “…the updated formulation provides the opportunity for [patients] to receive a vaccine more closely matched to current sublineages.”

Omicron XBB-related sublineages “continue to account for the vast majority of COVID-19 cases globally. The updated COVID-19 vaccine aims to further improve protection against severe illness and hospitalisation,” commented Professor Ugur Sahin, CEO and Co-founder of BioNTech.

Pfizer and BioNTech have filed an application with the US Food and Drug Administration (FDA) for approval of the Omicron XBB.1.5-adapted monovalent COVID-19 vaccine for individuals six months of age and older. A decision is anticipated soon.

Further news in the coronavirus vaccine space

In other recent news, on 29 Aug 2023, the World Health Organization (WHO)’s initiative COVID-19 Technology Access Pool (C-TAP), signed new licensing agreements on COVID-19 technologies. Eloisa del Pino, President of the Spanish National Research Council (CSIC) explained that the licensing agreement with C-TAP “opens the possibility of finding partners in third countries to advance clinical trials with this vaccine as a future alternative to licensed COVID vaccine options worldwide, especially in resource-poor countries.”

MHRA authorises new COVID-19 vaccine